Manager, Life Sciences, Regulatory Affairs

KPMG is currently seeking a Manager in Customer & Operations for our Consulting practice.

Responsibilities:

Lead consulting projects for Life Sciences clients focused on process improvements or technology implementations in the Regulatory Affairs function

Provide oversight of client and KPMG work teams throughout the project lifecycle and help ensure timely execution of project deliverables

Facilitate engagement decisions, including work plan and timeline, project management, resource allocation, and career development of team members

Structure and perform analysis on regulatory-related processes, data, business requirements, operating models, IT systems

Manage projects related to process transformation, operational improvements, and organizational redesign

Oversee projects related to system implementations and/or digital solutions

Qualifications:

Minimum of five years of work experience related to the Regulatory Affairs function within the pharmaceutical and/or medical device industry

Bachelors degree in an appropriate field from an accredited college/university; Masters degree from an accredited college/university preferred

Experience with operational process improvement initiatives in pharmaceutical and/or medical device industry

Prior professional services or consulting experience preferred

Strong understanding of Regulatory Affairs related data and documents

Experience with Regulatory Information Management (RIM) or Document Management systems preferred as well as experience serving on an implementation team for a RIM or Document Management system preferred